PUMA-G System™ 0010216

GUDID 00850026037074

Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape and Standard PUSH PEG Kit)

Coaptech, Inc.

Ultrasound-guided gastrostomy system catheter
Primary Device ID00850026037074
NIH Device Record Key72c53aaa-ee6d-453f-8672-e931a4a9d218
Commercial Distribution StatusIn Commercial Distribution
Brand NamePUMA-G System™
Version Model Number0010208
Catalog Number0010216
Company DUNS080322442
Company NameCoaptech, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com
Phone1 443 574 6934
Emailinfo@coaptech.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850026037050 [Primary]
GS100850026037074 [Package]
Contains: 00850026037050
Package: Shipper Box [2 Units]
In Commercial Distribution

FDA Product Code

KGCTube, Gastro-Enterostomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

On-Brand Devices [PUMA-G System™]

10850026037132External Magnet in Case
10850026037187Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037081Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037036Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit without Dr
00850026037074Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037098Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit with Drape
00850026037272Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037319Percutaneous Ultrasound Gastrostomy (PUG) System Full Procedural Kit (Convenience Kit and PUSH P
00860312001542External Magnet in Case
10850026037330Percutaneous Ultrasound Gastrostomy (PUG) System Essentials Kit
00860312001504Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
00850026037227Percutaneous Ultrasound Gastrostomy (PUG) System Balloon Catheter
10860312001556Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire
10850026037231Percutaneous Ultrasound Gastrostomy (PUG) System Guidewire with Pull Feature
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.